TENDRIL STS 2088TC/46 2088TC-46

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for TENDRIL STS 2088TC/46 2088TC-46 manufactured by St. Jude Medical, Inc.(crm-sylmar).

Event Text Entries

[185941641]
This product is registered as a combination product. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. Patient Sequence No: 1, Text Type: N, H10

[185941642]
Related manufacturer reference number: 2017865-2020-04495, 2017865-2020-04497. It was reported that the patient experienced an infection. The source of infection was unknown. The pacemaker system was explanted on (b)(6) 2020. The patient was stable. Patient Sequence No: 1, Text Type: D, B5